Bioequivalence and Bioavailability Forum

Blinded NCA [Study Performance]

posted by Helmut – Vienna, Austria, 2023-10-14 12:40 (57 d 21:46 ago) – Posting: # 23753
Views: 1,093

Hi Kim,

the bioanalytical part has to be blinded anyway.
I recommend to perform NCA in a blinded manner as well (i.e., sort the data by period and subject). Once you are done, lock the results and join the randomization (common keys: subject, period) and treatment.

For an example see this presentation (Case 1, slides 4–7). If NCA would have been performed unblinded (i.e., by treatment) the carry-over likely would not have been detected.

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Helmut Schütz

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Complete thread:

open-label BE trials maintain blindness kimhuang 2023-10-14 09:19 [Study Performance]
- Blinded NCAHelmut 2023-10-14 10:40
  - Blinded NCA kimhuang 2023-10-14 11:53
    - Blinded review of PK data: History… Helmut 2023-10-15 10:26
      - Blinded review of PK data: History… kimhuang 2023-10-16 00:43
- open-label BE trials maintain blindness ElMaestro 2023-10-14 17:39
  - open-label BE trials maintain blindness kimhuang 2023-10-15 00:56
    - open-label BE trials maintain blindness dshah 2023-10-17 09:25
      - open-label BE trials maintain blindness kimhuang 2023-10-18 00:50

Blinded NCA [Study Per­for­mance]

Complete thread:

Blinded NCA [Study Performance]